Pharmacological Management of Delirium (PMD)

Pharmacological Management of Delirium (PMD)

Overall Status:

Recruiting

Brief Description:

The purpose of this study is to develop and test the feasibility of using a specific pharmacological protocol to reduce delirium burden among older adults in the intensive care unit (ICU). The study will test the efficacy of a pharmacological intervention in reducing delirium severity and duration as well as length of stay and mortality compared to usual care.

Patient Qualifications:

Min Age

Max Age

Gender

Healthy Volunteers

18 Years

N/A

Both

No

Inclusion Criteria:

18 years of age or older

Hospitalized on an ICU ward

Delirium based on the RASS and the CAM-ICU assessments at any day during ICU stay

English speaking

Exclusion Criteria:

Admitted directly to a regular non-ICU ward

Previously enrolled in the study

Not eligible for delirium assessment as determined by RASS scores

Contraindications for use of haloperidol, such as history of torsades-de-pointes or allergic reaction to haloperidol

Prior history of severe mental illness

Alcohol-related delirium

Pregnant or nursing

Have had an aphasic stroke

Detailed Description:

In 2005, approximately 2.7 million Americans aged 65 and older spent at least 1 day in the intensive care unit (ICU), costing Medicare an estimated $27.5 billion. It is estimated that up to 80% of these older ICU patients had delirium, an often unrecognized acute brain failure that is an independent predictor of morbidity and mortality, during their hospital stay. Older adults with delirium are more prone to falls, injuries, and other complications that may also contribute to prolonged ICU and hospital length of stay, higher mortality rates, poorer functional status, and higher health care costs.

The literature supports treatment with a reduction in the use of benzodiazepines and anticholinergics and the use of low-dose neuroleptics such as haloperidol. However, there have been no randomized controlled trials evaluating the efficacy of this approach on reducing delirium severity, duration, and complications. This study will test a more targeted pharmacologic approach to the care of older adults with delirium, while still recognizing the clinicians' role in controlling symptoms and providing intensive care.

The hypothesis is that patients in the intervention arm, compared to those receiving usual care, will have reduced delirium severity, fewer hospital days with delirium or coma, shorter hospital lengths of stay, and lower ICU, hospital, and 30-day mortality.